a study to evaluate the efficacy and safety of cin-102 (deudomperidone) in adult subjects with idiopathic gastroparesis.

Conditions: Idiopathic Gastroparesis

Summary: the goal of this clinical trial is to evaluate if the study drug cin-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects. the main questions it aims to answer are: * to evaluate the efficacy of cin-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo * to evaluate the safety of cin-102 when given to patients with idiopathic gastroparesis compared to a placebo participants will go through the following schedule: * pre-screening (1 visit) * screening \& lead-in (1-2 visits) * will complete a gastric emptying breath test (gebt) * will complete daily diary and other patient reported outcomes (pros) as described in the protocol to assess eligibility for continued study participation. * lead-in period (1 visit) * 12-week treatment period (7 visits) * study drug taken twice daily by mouth * will complete daily diaries and other pros as described in protocol * 1 week follow-up (1 visit) researchers will compare the effects of the following treatments: * 15 mg cin-102, taken orally bid for 12 weeks * 10 mg cin-102, taken orally bid for 12 weeks * placebo for cin-102, taken orally bid for 12 weeks


Eligibility criteria:
key inclusion criteria: * is a male or female ≥18 years of age; * has a current diagnosis of gastroparesis defined by the following: 1. persistent gastrointestinal (gi) symptoms that, in the opinion of the investigator, are consistent with gastroparesis within 6 months prior to screening; and 2. documented delayed gastric emptying as determined by gastric emptying breath test (gebt) at visit 2. * body mass index between 17 and 45 kg/m2, inclusive; * if receiving treatment with a food and drug administration (fda)-approved and marketed glucagon-like peptide-1 receptor agonist (glp-1ra) for weight loss, may be considered for the study if all of the following criteria are satisfied: 1. has been on a stable dose of glp-1ra for at least 3 months before screening and is expected to maintain the same dose throughout the study, including during gebt; 2. is tolerating the glp-1ra well, according to the investigator's judgment; 3. in the opinion of the investigator, the study-qualifying signs/symptoms of gastroparesis are not solely due to the glp-1ra; 4. symptoms of gastroparesis were present before starting glp-1ra therapy; and 5. is not taking the glp-1ra for the management of diabetes or blood glucose control. ------------------------------------------------------------------------- key exclusion criteria: * has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing, or active viral illness; cancer, medications, musculoskeletal or connective tissue disorders \[eg, scleroderma, systemic lupus erythematosus\], or other neurologic disorder \[eg, parkinson's disease\]); * has a current diagnosis of type 1 or type 2 diabetes, according to the american diabetes association. pre-diabetes is not exclusionary; * has been hospitalized for gastroparesis or malnutrition within 3 months prior to screening; * has a known or suspected gi mechanical obstruction (eg, peptic stricture) as documented by upper gi endoscopy, upper gi radiographic series, plain film abdomen x-ray, or computed tomography (ct) in the past 2 years prior to randomization; * has a history of pyloric injection of botulinum toxin within 6 months of screening or planned injection(s) during the study; * has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy (g-poem) procedure; * has a history of gastric surgery; * has a history of or current diagnosis of intestinal malabsorption, recurrent or chronic pancreatitis, or other pancreatic exocrine disease; * has a history of severe and refractory constipation; * has a history or evidence of clinically significant arrhythmia; * currently receiving parenteral feeding or presence of a nasogastric or other enteral tube (e.g. percutaneous endoscopic gastrostomy \[peg\] or percutaneous endoscopic jejunostomy \[pej\] tube) for feeding or decompression; * has a substance use disorder or a positive alcohol or positive drug screen.

Keywords: gastroparesis idiopathic gastroparesis vomiting early satiety bloating epigastric pain abdominal pain delayed gastric emptying dopamine receptor antagonist nausea post-prandial fullness stomach pain gastric statis dysmotility gastric motility